Cleared Traditional

K162529 - DigiX FDX

K162529 is an FDA 510(k) clearance for DigiX FDX, manufactured by Allengers Medical Systems Limited. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K162529 · Allengers Medical Systems Limited · Radiology device
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Mar 2017
Decision
175d
Days
Class 2
Risk

K162529 is an FDA 510(k) clearance for the DigiX FDX. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Allengers Medical Systems Limited (Derabassi, Distt Mohali, IN). The FDA issued a Cleared decision on March 3, 2017 after a review of 175 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Allengers Medical Systems Limited devices

FDA 510(k) Submission Details - K162529

510(k) Number K162529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2016
Decision Date March 03, 2017
Days to Decision 175 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 107d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KPR System, X-ray, Stationary

All 190
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K162529.
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